FDA Adverse Event
Malfunction
Summary report: N
LECTROVAC 6-INCH
MDR report key: 897399
·
Received August 14, 2007
Report
- Report Number
- 1717344-2007-00247
- Event Type
- Malfunction
- Date Received
- August 14, 2007
- Date of Event
- July 16, 2007
- Report Date
- July 17, 2007
- Manufacturer
- VALLEYLAB
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
IF THE SUSPECT MEDICAL DEVICE IS RETURNED A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
THE INITIAL REPORT CAME IN AS A SERVICE REQUEST FOR AN ELECTROSURGICAL GENERATOR STATING IT HAD BEEN INVOLVED IN A PATIENT INCIDENT. FOLLOW-UP WITH THE SITE FOUND THERE HAD BEEN A BURN TO A JUVENILE PATIENT'S LIP. THERE WAS A 2ND DEGREE BLISTER THE SIZE FO A PEA. NO TREATMENT WAS GIVEN FOR THE BLISTER AND THE PATIENT WAS RELEASED. THE SITE STATED THAT THERE WAS NO ALLEGATION OF MALFUNCTION AT THIS TIME, AND THEY BELIEVE THERE MAY HAVE BEEN INADVERTENT ARCING TO A METAL MOUTH-GUARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LECTROVAC 6-INCH | ELECTROSURGICAL ACCESSORY | GEI | VALLEYLAB | 122875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | MEGADYNE CAUTERY TIPS| E7507-RETURN ELECTRODE - LOT 124809| E2516H-ESU PENCIL - LOT 124256| FORCE1C20-ESU GENERATOR |